Responsible for the supervision of laboratory personnel and all activities related to Microbiology.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Supervise daily laboratory activities and laboratory scheduling to ensure optimum group performance.
•Train technical personnel in general laboratory skills; reinforce regulatory concepts (cGMP) and specific laboratory techniques.
•Perform technical troubleshooting.
•Develop assays that meet regulatory guidelines.
•Work directly with clients to provide necessary information regarding on-going projects.
•Provide guidance and updates to the Customer Service and Client Account Management departments handling customer relations.
•Revise documents to ensure that the Microbiology laboratory maintains its compliance status.
•Assess and evaluate the current environmental monitoring program, and develop an implementation plan to enhance and align the current program with both industry best practices and regulatory/compendial recommendations.
•Develop/revise the environmental monitoring database to enter all subsequent data and perform trend analysis on monitored locations/personnel through the implementation of statistical expression.
•Execute and/or oversee the performance of microbiology-based testing methods, such as but not limited to, mycoplasma and mycoplasmastasis testing, bioburden (pour-plate and membrane filtration), sterility (direct inoculation and membrane filtration), bacteriostasis and fungistasis, bacteriophage testing, environmental monitoring, tuberculosis testing, viability, purity, and light/fluorescent microscopy.
•Assist in development of business management review slides for presentation to senior management.
•Assist in the standardization of pricing for microbiology assays, and develop a pricing scale as needed.
•Develop and write validation, qualification or large study project reports.
•Oversee maintenance of group training manual and training records.
•Oversee daily operational activities and supervise a group of non-exempt employees. Ensure optimum group performance.
•Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
•Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans.
•Assist in development of departmental budget.
•Support the policy of equal employment opportunity through affirmative action in personnel actions.
•Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
•Perform all other related duties as assigned.Qualifications
•Education: Bachelor’s degree (B.S./B.A.) or equivalent in biology or a related discipline.
•Experience: Minimum of 4-6 years related laboratory/supervisory experience.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Other: Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet